Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Sohaib Ashraf
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- HRCT chest
Study Overview
Brief Summary
The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Detailed Description
The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
empty capsule will be given as a placebo
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive PCR with mild to moderate disease
Exclusion Criteria
- •Allergic to iodine
- •Any co-morbidity other than hypertension and dietetics
Arms & Interventions
Iodine Complex (Capsule form)
Iodine Complex) capsule (200mg) will be given three times a day
Intervention: Iodine Complex (Drug)
Iodine Complex (Syrup form)
Iodine Complex syrup form (40ml) will be given three times a day
Intervention: Iodine Complex (Drug)
Standard Care Alone
Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.
Intervention: Placebo (Drug)
Iodine Complex (Nasal Spray)
Iodine complex throat spray of 2 puffs three times a day.
Intervention: Idoine Complex (Drug)
Outcomes
Primary Outcomes
HRCT chest
Time Frame: 14 days
Time taken for radiological improvement
qRT-PCR
Time Frame: 14 days
Time taken for viral load clearance
Secondary Outcomes
- Severity of Symptoms(14 days)
Investigators
Sohaib Ashraf
Post-Graduate Resident Cardiology
Sheikh Zayed Federal Postgraduate Medical Institute